Kornimate/medical-research-clean huggingface dataset:
grafts of gscs into brain organoids for testing anti-invasion drugs

Conditions: Glioblastoma; Glioma, Malignant

Summary: in patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and ipscs from skin fibroblasts or pbmcs. brain organoids will be generated from ipscs and co-cultured with ipscs to study brain invasion and ciliogenesis. 3d genome architecture of glioma stem-like cells will be investigated. gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.


Eligibility criteria:
inclusion criteria: o be enrolled in the study patients must: 1. have a radiological diagnosis of supratentorial glioblastoma, or 2. have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with rano criteria (wen, 2010); 3. be a candidate to neurosurgery for glioblastoma; 4. be of an age of 18 years or above; 5. provide written informed consent for participation to the study. exclusion criteria to be enrolled in the study patients must not: 1. have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the principal investigator; 2. have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 who classification.

Keywords: glioma stem-like cells brain organoids brain invasion ciliogenesis
comparison of the blood sugar lowering effect between repaglinide plus metformin and repaglinide alone in type 2 diabetics not previously treated with oral sugar-lowering drugs

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in chinese subjects with type 2 diabetes having an hba1c (glycosylated haemoglobin a1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. the associated unfavourable events including low blood sugar episodes between the two treatments are also compared.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * never taken oral antidiabetic drugs before * hba1c greater than 8.5 % * bmi (body mass index) less than or equal to 35 kg/m\^2 exclusion criteria: * known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications * taken an investigational drug in another clinical trial within 4 weeks prior to this trial * impaired liver function, defined as asat (aspartate aminotransferase) or alat (alanine aminotransferase) equal to or greater than 2 times upper normal limit * have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems * severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (bp) equal to or greater than 100 mmhg or systolic bp equal to or greater than 180 mmhg) * impaired renal function * acute or chronic acidosis or if there are plans to have a radiographic material containing iodine * have a clinically significant, active cardiovascular disease, or decompensated heart failure * treatment with systemic corticosteroids within the past two months prior to screening
fuzhenghuayu for patients with pbc who had an inadequate response to ursodeoxycholic acid

Conditions: Primary Biliary Cirrhosis

Summary: ursodeoxycholic acid (udca) has been the only treatment for pbc approved by us and european drug administrations. long-term use of udca(13-15 mg/kg/day) in patients with pbc improves serum liver biochemistries and survival free of liver transplantation however, about 40% of patients do not respond to udca optimally as assessed by known criteria for biochemical response. those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. and udca has less effect on pbc patients whose pathology stage 3-4. liver fibrosis might jeopardize the udca effect. fuzhenghuayu is a chinese traditional medicine for liver fibrosis and cirrhosis. both lab research and some clinical studies suggest that fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. here we start a random, open and parallel clinical research to explore the effect of fuzhenghuayu combined with udca in the pbc treatment.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. patient with pbc defined by 2 in 3 of the following criteria: a.positive antimitochondrial antibody type m2; b.abnormal serum alkaline phosphatases (alp \> 1,5n) and aminotransferase (ast or alt \> 1n) activities; c.histological hepatic injuries consistent with pbc. 3. had been treated with udca more than 6 months, and failed to achieve a complete biochemical response. exclusion criteria: 1. pregnancy or desire of pregnancy. 2. breast-feeding. 3. co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, wilson's disease and hemochromatosis. 4. history or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites). 5. history of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn). 6. hepatotoxic drugs use before recruiting. 7. fuzhenghuayu anaphylaxis.

Keywords: fuzhenghuayu
epidemiology of depression, anxiety, and cognitive impairment

Conditions: Depression; Anxiety; Cognitive Impairment

Summary: many older adults have undetected health problems and lack basic prevention measures. failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. alternate sites for screening and intervention have begun to receive attention and may hold promise. the emergency department (ed) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. however, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ed. second, a question remains as to the validity of screening patients during an acute illness. upon completion, this study will describe the epidemiology of the population of older adults presenting to the ed.

many older adults have undetected health problems and lack basic prevention measures. failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. alternate sites for screening and intervention have begun to receive attention and may hold promise. the emergency department (ed) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. however, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ed. second, a question remains as to the validity of screening patients during an acute illness. this study aims to: 1. compare the prevalence of depression and cognitive impairment among patients who arrive at the ed by ems, as compared to those arriving via other means. 2. evaluate the reliability of screening patients for depression and cognitive impairment during an acute illness and after the illness. 3. to evaluate correlates of depression, anxiety and suicidal ideation. upon completion, this study will describe the epidemiology of the population of older adults presenting to the ed.

Eligibility criteria:
inclusion criteria: * age 60 and older * arrival at ed exclusion criteria: * institutionalized

Keywords: depression anxiety cognitive impairment emergency medicine prehospital care
safety and tolerability of i-040302 in children and young adults with solitary bone cysts

Conditions: Bone Cysts

Summary: this is a randomised, controlled, open-label study of a single intralesional administration of i-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). subjects will undergo screening with x-ray and magnetic resonance imaging (mri) in the diagnosis of a solitary bone cyst.


Eligibility criteria:
inclusion criteria: 1. subjects 6 - 16 years of age 2. diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods: * cyst fluid examination * plain radiographs * mri 3. subjects with the following types of cysts: * intact cysts that are either growing or at risk of fracture, requiring surgical intervention * persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture * persistence of a cyst cavity despite repeated interventions 4. subjects with bone cyst volumes \< 30 ml 5. subjects must be appropriately communicative to verbalise pain. 6. subjects must be able to understand and be willing to comply with the protocol procedures. 7. subjects who have provided written informed consent to participate in the study 8. the legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study. exclusion criteria: 1. a history of/or presence of active cancer 2. family history of retinoblastoma 3. indication of aneurysmal bone cyst on mri, cyst aspiration or histology 4. possible presence of osteosarcoma or uncertain histology 5. systemic or localised infection at time of surgery 6. evidence of immune-suppression 7. evidence of hypercalcemia 8. cyst volume \> 30 ml 9. fracture present in the cortical bone surrounding the cyst 10. evidence of rapid venous drainage from the cyst determined by rapid disappearance of x-ray contrast medium during the surgical process. 11. suspected or known evidence of allergic reactions towards any of the components of i-040302 12. known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study 13. pregnant or lactating females 14. participation in another clinical trial within 3 months prior to trial start

Keywords: osteogenic gel solitary bone cysts
vaccination in the peripheral stem cell transplant setting for multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (gm-csf) producing cell line.


Eligibility criteria:
inclusion criteria: * de novo multiple myeloma * ecog 0-2 * no serious co-morbid illnesses and adequate organ function * \> 4 weeks from systemic steroids exclusion criteria: * no existing secondary malignancies and no history of secondary malignancies in the past 5 years * no active autoimmune disease

Keywords: multiple myeloma cancer psct peripheral stem cell transplant chemotherapy gvax
progressive relaxation exercise applied to palliative caregivers on coping with stress,anxiety

Conditions: Palliative Care

Summary: it is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems.

cognitive-behavioral methods, which may be applied as relaxation aids in controlling the anxiety levels.

Eligibility criteria:
inclusion criteria: * to be able to communicate adequately * not having psychiatric problems * volunteering to participate in research * caregivers whose patients will be in bed for at least 4 weeks exclusion criteria: * none

Keywords: progressive relaxation exercise coping with stress anxiety
beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer

Conditions: Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Compression

Summary: this pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. a bone graft may help healing and bone growth in patients undergoing surgery for spine cancer

objectives: i. to determine if chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. ii. to evaluate quality of life following the use of chronos as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. outline: patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. after completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.

Eligibility criteria:
inclusion criteria: * all patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion * patients may or may not have posterolateral instrumentation exclusion criteria: * status-post previous fusion with allogeneic bone graft
prevention of paclitaxel neuropathy with cryotherapy

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.


Eligibility criteria:
inclusion criteria 1. women 18 years of age or older 2. histologically or cytological proven diagnosis of breast cancer stage i- iii. 3. must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting. 4. may have received prior treatment including, radiation, surgery chemotherapy hormone and biologics. 5. eastern cooperative oncology group (ecog) performance status ≤ 1 6. patient signed informed consent. 7. patient willing and able to comply with scheduled visits and treatment plan. exclusion criteria 1. patient presents with grade 2 or greater peripheral neuropathy. 2. history of raynaud's disease. 3. patient presents open or poorly-healing wounds on the hands or feet. 4. patients with cold intolerance. 5. patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.

Keywords: cryotherapy cold therapy peripheral neuropathy paclitaxel breast cancer symptom management prevention
magnetoencephalography in children

Conditions: Epilepsy; Intracranial Tumors; Cerebrovascular Disease; Autism; ADHD - Attention Deficit Disorder With Hyperactivity; Neuropsychiatric Disorders; Tic Disorder, Childhood; Mental Retardation; Developmental Disabilities

Summary: this study is a single-center observational clinical study, which evaluates the diagnostic value of magnetoencephalography (meg) in the diagnosis of neurodevelopmental diseases in children, such as the localization of epileptic foci and brain functional areas, intracranial tumors, cerebrovascular diseases, autism, mental retardation, and neuropsychiatric disorders.

the purpose of this study is to observe the application of magnetoencephalography (meg) in pediatric neurodevelopmental disorders

Eligibility criteria:
inclusion criteria: 1. aged 1 month-18 years old (date of investigate minus date of birth) 2. epilepsy 3. intracranial tumors 4. cerebrovascular diseases 5. autism 6. mental retardation 7. adhd 8. tic disorder 9. neuropsychiatric disorders exclusion criteria: 1.unable to cooperate with the exam of meg

Keywords: neurodevelopmental diseases magnetoencephalography pediatric
gases humidification during noninvasive ventilation : heat and moisture exchanger or heated humidifier ?

Conditions: Acute Lung Injury; Pneumonia; Chronic Obstructive Pulmonary Disease; Acute Heart Failure

Summary: to humidify gases during non invasive ventilation, both to heated humidifier (hh) and heat and moisture exchanger (hme) are routinely used. patients receiving non invasive ventilation for acute respiratory failure were randomized to hme or hh. the purpose of this study was to evaluate respiratory parameters and arterial blood gases (abg) of patients during niv with small dead space hme compared to hh.

objective: few data are reported in the field of noninvasive ventilation (niv) regarding humidification devices. it was previously suggested that standard heat and moisture exchangers (hme) had adverse gasometrical and clinical outcomes in acute respiratory failure (arf) of chronic respiratory failure patients (crf). this study was performed to evaluate respiratory parameters and arterial blood gases (abg) of patients during niv with small dead space hme compared to heated humidifier (hh). design: prospective randomized cross-over study. setting: a 16-bed medical intensive care unit (icu) and a 14-bed medico surgical icu. patients: patients receiving niv for arf in the context of crf or hypoxic arf and patients with persistent weaning failure receiving niv just after extubation. measurements: hme and hh were randomly compared during 2 niv periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen. abg were collected at baseline and at the end of each period. as well as respiratory parameters including volumes, pressures, p0.1, a comfort score, capnometry and oxygen saturation. two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not.

Eligibility criteria:
inclusion criteria: * patients receiving niv for arf in the context of crf, hypoxic arf or patients with persistent weaning failure receiving niv just after extubation exclusion criteria: -

Keywords: humidification heat and moisture exchanger heated humidifier, non invasive ventilation
an observational follow-up study to evaluate duration of treatment effect of pentosan polysulfate sodium in participants with knee osteoarthritis pain

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (pps) compared with placebo in adult participants with knee osteoarthritis (oa) pain. the study duration will be up to 34 weeks. participants who completed pday 162 of study para_oa_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.

this is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post pps use for 6 weeks in parent study (para_oa_002). the duration of treatment effect will be evaluated by the omeract-oarsi responder criteria for knee oa. eligible participants will be enrolled in study para_oa_006 at the completion of the parent study para_oa_002. there will be no intervention in this observational study. participants will attend screening (visit 1), three phone visits at 8, 16, and 24 weeks, and an eos (end of study) visit 34 weeks at the site, a total of 5 visits. participants questionnaires include womac (western ontario and mcmaster universities osteoarthritis index) nrs 3.1 index, pgic (patients global impression of change), wpai (work productivity and activity impairment) and quality of life sf-36.

Eligibility criteria:
inclusion criteria: * participants who completed day 168 of study para_oa_002 (ie, did not discontinue/withdrew prematurely from the parent study). * capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: • an employee of the sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.

Keywords: osteoarthritis knee
comparative study of static and dynamic back supports for lower back pain

Conditions: Low Back Pain, Mechanical

Summary: lower back pain is one of the most common conditions affecting humans. lower back supports are a common device used in order to alleviate the pain. all the available back supports are wrapped around the lower back and abdomen and act as static support devices. "the hug" is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. this trial compares both devices and their effect on reducing lower back pain.


Eligibility criteria:
inclusion criteria: * recurrent back pain * use analgesics exclusion criteria: * pregnant women * malignancy * infection * neurological condition * surgical candidate

Keywords: back pain posture lumbar support dynamic support
effects of task-oriented intervention in children with developmental coordination disorder

Conditions: Developmental Coordination Disorder

Summary: physical coordination is impacted by developmental coordination disorder (dcd), commonly referred to as dyspraxia. it makes a youngster appear to move clumsily and perform worse than expected in everyday tasks for their age. fine and gross motor coordination issues are a hallmark of this neurodevelopmental disorder. task-oriented therapies help children with dcd develop their skills, coordination, and manipulative abilities by including them in intentional, goal-directed tasks. this is noteworthy because a child's quality of life can be greatly impacted by these skills, which are essential for everyday tasks like writing, tying shoelaces, walking, and balance. the purpose of the research is to ascertain how task-oriented upper limb intervention affects children with impaired coordination and hand-eye coordination.

the task-oriented intervention aimed at the upper limbs will be administered to the intervention group. for 3 months, interventions were offered 3 days a week.over the course of 6 months, this quasi-experimental study will be carried out in lahore. data will be gathered from the harbanspura branch of the punjab school and the askari school system in mughalpura. there will be 18 students in the study. the study's inclusion criteria will be children with developmental coordination disorders between the ages of 4 and 12 youngsters needed to be able to comprehend and adhere to instructions, both boys and girls who scored between 15 and 57 overall on the developmental coordination disorder questionnaire 2007.children with congenital respiratory, cardiovascular, or musculoskeletal disorders, as well as those with unstable seizures, will be excluded. both before and after the operation, data will be gathered. the movement assessment battery for children (mabc-2), the developmental coordination disorder questionnaire, and the abil hand kid instrument will be used to assess subjects with developmental coordination disorders.

Eligibility criteria:
inclusion criteria: * developmental coordination disorder children aged 4 to 12 years old. * have a total score of 15-57 on the developmental coordination disorder questionnaire2007. * children had to be able to understand and follow instructions. * boys and girls both are included exclusion criteria: * children with unstable seizures will be excluded. * dcd children with any congenital cardio-respiratory condition, congenital musculoskeletal condition. * dcd children with severe visual and/or hearing disability preventing them from completing exercises prescribed by either program. * children with behavioral difficulty making them unable to complete exercises prescribed by either program

Keywords: developmental coordination disorder task-oriented intervention upper limb